2016 Annual Report of the Federal Select Agent Program: Infographic of Findings

FEDERAL SELECT AGENT PROGRAM

2016 Annual Report | Key Statistics

The 2016 Annual Report of the Federal Select Agent Program provides continued insight into the work conducted with biological select agents and toxins at laboratories across the nation, as well as the regulatory functions of the Federal Select Agent Program (FSAP). This annual report is FSAP’s second report of aggregate program data, and reflects the program’s ongoing commitment to transparency and increasing understanding of the program.

• FSAP is managed jointly by the Centers for Disease Control and Prevention’s Division of Select Agents and Toxins & the Animal and Plant Health Inspection Service’s Agriculture Select Agent Services
• FSAP regulates the possession, use, and transfer of biological select agents and toxins (BSAT) so that important work with potentially dangerous and deadly pathogens is conducted as safely and securely as possible
• BSAT are materials that have the potential to pose a severe threat to public, animal or plant health, or to animal or plant products

276 ENTITIES WERE REGISTERED WITH FSAP

• 32% ACADEMIC
• 18% COMMERCIAL
• 15% FEDERAL GOVERNMENT
• 29% NON-FEDERAL GOVERNMENT
• 6% PRIVATE

51% of entities are registered for Tier 1* BSAT

LAB BIOSAFETY LEVELS (BSL)

ENTITIES MAY HAVE MULTIPLE TYPES

• 32% have BSL-2 and/or ABSL-2 labs
• 80% have BSL-3 and/or ABSL-3 labs
• 3% have BSL-4 and/or ABSL-4 labs

TOP REGISTERED AGENTS BY AGENCY

CDC’s Division of Select Agents and Toxins

1. Brucella melitensis
2. Brucella suis
3. Brucella abortus
4. Bacillus anthracis
   (Pasteur strain)
5. Francisella tularensis*

APHIS’s Agriculture Select Agent Services

1. Newcastle disease virus
2. Avian influenza virus
3. Bacillus anthracis*
4. Brucella abortus
5. Ralstonia solanacearum

COMPLIANCE & ENFORCEMENT

• 5 entities agreed to participate in a corrective action plan
• 3 entities were put under suspension
• 0 instances of criminal intent found for the 12 matters of which FBI was notified
• 3 entities were referred to the HHS Office of Inspector General or APHIS Investigative and Enforcement Services

THEFT, LOSS, & RELEASE

• 0 thefts reported
• 177 incidents involving potential occupational exposures reported (resulting in monitoring for 998 laboratory workers)
• 8 reports of losses determined to be records management errors
• 0 potential exposures resulting in illness, death, or transmission

TRANSFER APPROVALS: 188 DSAT | 72 AgSAS

• 38% of the transfers were from unregistered entities to registered entities, mostly as a result of identification of BSAT in a diagnostic specimen

181 TOTAL INSPECTIONS CONDUCTED BY FSAP

• 103 by DSAT
• 29 by AgSAS
• 49 joint DSAT & AgSAS

3 AVERAGE DURATION (IN DAYS) FOR INSPECTION

• Range of 1 to 8 days

3,982 SECURITY RISK ASSESSMENTS APPROVED IN 2016

• Denied access for 10 individuals

KEY ABBREVIATIONS:

• FSAP: Federal Select Agent Program
• CDC: Centers for Disease Control and Prevention
• DSAT: Division of Select Agents and Toxins
• APHIS: Animal and Plant Health Inspection Service
• BSAT: Biological select agents and toxins
• AgSAS: Agriculture Select Agent Services
• ABSL: Animal biosafety level

*Tier 1 agent, those that pose the greatest risk through misuse

Source: 2016 Annual Report of the Federal Select Agent Program, October 2017 | www.selectagents.gov/annualreport2016.htmlexternal icon